FDA-Device2025-04-16Class II
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
BioFire Diagnostics, LLC
Hazard
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Sold states
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Affected count
29 kits
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief